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Wil je zoals deze

Derksenderks - via Monster Worldwide - Leiden - 09-11-2019 Naar vacature  

  • a position where your experience is recognized
  • working for an international company
  • contract until at least May 2020

Organisation

Our client is an international pharmaceutical company. The company's activities comprise the development, production and sales of medicines. They have several locations in The Netherlands and are willing to hire a new team member for the facility in Drenthe or Zuid-Holland. They would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented Senior Associate Manager Quality Management Systems.

Position

As a Senior Associate Manager Quality Management Systems you are responsible for the development and maintenance of the Quality Management System (QMS) Corrective and Preventive Management (CAPA) system supporting Regulatory Affairs, Pharmacovigilance, Development, Medical Affairs and other functions that utilize the Medical and Development QMS. You will contribute to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 year strategic plan. In this role you will function as the Quality System (QD) Administrator and you will be responsible for reviewing new or revised CAPA Documents for compliance to established standards. Besides this you will ensure all CAPA’s meet required standards. These standards includes identification of applicable process stakeholders in the management of CAPA activities, communication of process / system requirement and standards to issue owners, QA contacts, and oversight functions. Besides this you will make sure the completion of documentation is accuracy and timely. As a Senior Associate Manager Quality Management Systems you will maintain the development and distribution of compliance status reports to oversight functions within M&D. Besides this you are responsible for monitoring the CAPA mailbox and responding to email inquiries and user support questions. Other tasks may include supporting the on the job training of new users and the application to the CAPA management process.

Profile

  • Associates of Arts / Associates of Science degree AS/AA
  • minimum of 1 year working experience in the pharmaceutical industry, within quality assurance, project managment, process improvement or similar discipline
  • proficiency in Microsoft Office
  • detail orientationed ability to convert data and assure integrity into created metric reports and oversight presentation
  • strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration
  • excellent oral and written communication
  • strong planning and organizational skills and experience managing multiple priorities simultaneously
  • experience with CAPA management, TrackWise systems and/or Qlikview programming would be an advantage
  • preferred location for this position is Northbrook (IL), United States; Leiden, Netherlands; or Tokyo, Japan

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-161-DD, to Djamila Hagemans:
.
For further information, please call Djamila Hagemans at number +31 (0)33 472 80 87.
An individual assessment may be part of the selection procedure.
Our Client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

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